Last updated: 11/23/20

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ADC Therapeutics Announces FDA Accepts Biologics License Application and Grants Priority Review for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma(ADC Therapeutics Press Release)
ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status.
Diffuse Large B Cell Lymphoma | loncastuximab tesirine
Evidence: B - Late Trials
4 days ago
LBA-4 Efficacy and Safety Results from ASCEMBL, a Multicenter, Open-Label, Phase 3 Study of Asciminib, a First-in-Class STAMP Inhibitor, vs Bosutinib (BOS) in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Previously Treated with =2 Tyrosine Kinase Inhibitors (TKIs(ASH 2020)
...At baseline, ≥1 BCR-ABL1 mutation was present in 12.7% pts...asciminib, a first-in-class STAMP inhibitor, demonstrated statistically significant and clinically meaningful superiority in efficacy compared with BOS (primary objective), deeper MR rates, and a favorable safety profile. These results support the use of asciminib as a new treatment option in CML, particularly in R/I pts who received ≥2 prior TKIs.
BCR-ABL1 fusion | Chronic Myeloid Leukemia | ABL001
Evidence: B - Late Trials
4 days ago
Day One Announces Preliminary Phase 1 Results for DAY101 in Pediatric Low-Grade Glioma, Receipt of Breakthrough Therapy Designation (BTD) and New Phase 2 Study(Press Release)
The US Food and Drug Administration (FDA) has granted DAY101 BTD for the treatment of pediatric patients with advanced low-grade glioma harboring RAF alteration.
BRAF fusion | Glioma | DAY101
Evidence: C3 – Early Trials -> B - Late Trials
5 days ago
Nucleix’s BE Safe @Home Project brings bladder cancer surveillance to patients’ homes during COVID-19 pandemic and beyond(Businesswire)
"Nucleix…announced the launch of its BE Safe @Home project to bring surveillance for recurrence of non-muscle invasive bladder cancer (NMIBC) to patients’ homes with its Bladder EpiCheck® urine test. This initiative was developed after consulting with world-leading urologists in an effort to make surveillance more convenient for patients during COVID-19 and beyond. The project is implemented in Israel, Spain and the Netherlands." "
Bladder EpiCheck® / Nucleix
Launch
5 days ago
Agendia and Paige announce landmark strategic partnership to revolutionize treatment planning in breast cancer(Agendia Press Release)
"Agendia, Inc…and Paige…today announced a first of its kind strategic partnership that will redefine precision oncology. The partnership will enable co-development of treatment planning tools that integrate the cloud-based Paige Platform with genomic information from Agendia’s proprietary MammaPrint® and BluePrint® diagnostic tests for patients with breast cancer. These new products will enable faster access to predictive and prognostic information along the entire continuum of care, from diagnosis and early intervention to metastatic treatment planning."
BluePrint / Agendia; MammaPrint / Agendia
Licensing / partnership
5 days ago
PTC Therapeutics Announces Key Regulatory Designations for PTC596 to Advance Treatment of Two Rare Oncology Indications(PTC Therapeutics Press Release)
PTC Therapeutics, Inc. (NASDAQ: PTCT), today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted PTC596 both Orphan Drug Designation and Fast Track designation for the potential treatment of leiomyosarcoma (LMS), a rare type of cancer that affects smooth muscle tissue.
Leiomyosarcoma | PTC596
Evidence: B - Late Trials
6 days ago
Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: A subgroup analysis of germline BRCA1 or BRCA2 mutations from the phase 3 BROCADE6(SABCS 2020)
The proportion of as-treated pts with BRCA1 or BRCA2 mutations was comparable between the Vel + C/P (51.4% BRCA1, 48.6% BRCA2) and Pbo + C/P (50.9% BRCA1, 49.1% BRCA2) study arms...Investigator-assessed PFS for the Vel + C/P and Pbo + C/P arms was 14.2 mo vs 12.6 mo, respectively, in the BRCA1 subgroup (HR=0.75 [95% CI: 0.55, 1.03]; P=0.073) and 14.6 mo vs 12.6 mo, respectively, in the BRCA2 subgroup (HR=0.69 [95% CI: 0.50, 0.95]; P=0.021)
BRCA2 mutation | HER2 Negative Breast Cancer | ABT-888 + QR 207
Evidence: B - Late Trials
7 days ago
Genomic profiling and clinical outcomes with first-line atezolizumab and nab-paclitaxel in triple-negative breast cancer: An exploratory analysis from the phase 3 IMpassion130 tria(SABCS 2020)
...CNA in CDKN2A (12%) and CDKN2B (11%) were associated with improved PFS and OS clinical activity in the A + nP arm vs the P + nP arm (HR PFS, 0.43-0.44 and HR OS, 0.47, respectively).
CDKN2A mutation | Triple Negative Breast Cancer | atezolizumab
Evidence: B - Late Trials
7 days ago
BeiGene Announces that RATIONALE 303 Trial of Tislelizumab in Non-Small Cell Lung Cancer Met the Primary Endpoint of Overall Survival at Interim Analysis(BeiGene Press Release)
BeiGene, Ltd....today announced that the RATIONALE 303 trial of its anti-PD-1 antibody tislelizumab versus docetaxel in the second- or third-line setting in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)...met its primary endpoint of overall survival (OS) in the intention-to-treat (ITT) patient population at the planned interim analysis, as recommended by the independent Data Monitoring Committee (DMC).
PD-L1 overexpression | Non Small Cell Lung Cancer | tislelizumab
Evidence: C3 – Early Trials -> B - Late Trials
7 days ago
Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: A subgroup analysis of germline BRCA1 or BRCA2 mutations from the phase 3 BROCADE4(SABCS 2020)
The proportion of as-treated pts with BRCA1 or BRCA2 mutations was comparable between the Vel + C/P (51.4% BRCA1, 48.6% BRCA2) and Pbo + C/P (50.9% BRCA1, 49.1% BRCA2) study arms...Investigator-assessed PFS for the Vel + C/P and Pbo + C/P arms was 14.2 mo vs 12.6 mo, respectively, in the BRCA1 subgroup (HR=0.75 [95% CI: 0.55, 1.03]; P=0.073) and 14.6 mo vs 12.6 mo, respectively, in the BRCA2 subgroup (HR=0.69 [95% CI: 0.50, 0.95]; P=0.021)
BRCA2 mutation | HER2 Negative Breast Cancer | carboplatin + ABT-888
Evidence: B - Late Trials
7 days ago
Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: A subgroup analysis of germline BRCA1 or BRCA2 mutations from the phase 3 BROCADE5(SABCS 2020)
The proportion of as-treated pts with BRCA1 or BRCA2 mutations was comparable between the Vel + C/P (51.4% BRCA1, 48.6% BRCA2) and Pbo + C/P (50.9% BRCA1, 49.1% BRCA2) study arms...Investigator-assessed PFS for the Vel + C/P and Pbo + C/P arms was 14.2 mo vs 12.6 mo, respectively, in the BRCA1 subgroup (HR=0.75 [95% CI: 0.55, 1.03]; P=0.073) and 14.6 mo vs 12.6 mo, respectively, in the BRCA2 subgroup (HR=0.69 [95% CI: 0.50, 0.95]; P=0.021)
BRCA1 mutation | HER2 Negative Breast Cancer | ABT-888 + QR 207
Evidence: B - Late Trials
7 days ago
E2112: Randomized phase 3 trial of endocrine therapy plus entinostat/placebo in patients with hormone receptor-positive advanced breast cancer. A trial of the ECOG-ACRIN cancer research group(SABCS 2020)
The combination of exemestane and entinostat did not improve survival in AI resistant advanced HR-positive, HER2-negative breast cancer.
HR positive + HER-2 negative | HER2 Negative Breast Cancer | SNDX-275
Evidence: B - Late Trials
7 days ago
Genomic profiling and clinical outcomes with first-line atezolizumab and nab-paclitaxel in triple-negative breast cancer: An exploratory analysis from the phase 3 IMpassion130 trial(SABCS 2020)
...CNA in CDKN2A (12%) and CDKN2B (11%) were associated with improved PFS and OS clinical activity in the A + nP arm vs the P + nP arm (HR PFS, 0.43-0.44 and HR OS, 0.47, respectively).
CDKN2B mutation | Triple Negative Breast Cancer | atezolizumab
Evidence: B - Late Trials
7 days ago
Correlative biomarker analysis of intrinsic subtypes and efficacy across the MONALEESA Phase III studies(SABCS 2020)
Patients with HER2E (hazard ratio [HR], 0.389; P < .0001), LumB (HR, 0.521; P = .0001), LumA (HR, 0.633; P = .0007), and normal-like (HR, 0.467; P = .0005) subtypes all derived benefit from RIB treatment,...Patients with HER2E, LumA, LumB, and normal-like subtypes all exhibited a consistent PFS benefit with RIB treatment, while patients with basal-like ABC (RIB: 2%; PBO: 3%) did not. The HER2E subtype (RIB: 14%; PBO: 11%) exhibited the greatest relative reduction in risk of progression or death (61%) with RIB plus ET.
ER positive + PGR positive + HER-2 positive | Breast Cancer | ribociclib
Evidence: B - Late Trials
7 days ago
Safety and efficacy of veliparib plus carboplatin/paclitaxel in patients with HER2-negative metastatic or locally advanced breast cancer: A subgroup analysis of germline BRCA1 or BRCA2 mutations from the phase 3 BROCADE3()
The proportion of as-treated pts with BRCA1 or BRCA2 mutations was comparable between the Vel + C/P (51.4% BRCA1, 48.6% BRCA2) and Pbo + C/P (50.9% BRCA1, 49.1% BRCA2) study arms...Investigator-assessed PFS for the Vel + C/P and Pbo + C/P arms was 14.2 mo vs 12.6 mo, respectively, in the BRCA1 subgroup (HR=0.75 [95% CI: 0.55, 1.03]; P=0.073) and 14.6 mo vs 12.6 mo, respectively, in the BRCA2 subgroup (HR=0.69 [95% CI: 0.50, 0.95]; P=0.021)
BRCA1 mutation | HER2 Negative Breast Cancer | carboplatin + ABT-888
Evidence: B - Late Trials
7 days ago
Pathologic complete response and 3-year survival with or without pertuzumab using real-world data of stage II and III HER2-positive breast cancer(SABCS 2020)
Pertuzumab use improved pCR rates (65% vs 41%, adjusted odds ratio [aOR] 3.01; 95% confidence interval [CI] 2.29-3.97; p<0.001)….the efficacy of pertuzumab to achieve a pCR in stage II and III HER2-positive breast cancer...
HER-2 positive | HER2 Positive Breast Cancer | pertuzumab
Evidence: B - Late Trials
7 days ago
Correlative biomarker analysis of intrinsic subtypes and efficacy across the MONALEESA Phase III studies(SABCS 2020)
Patients with HER2E (hazard ratio [HR], 0.389; P < .0001), LumB (HR, 0.521; P = .0001), LumA (HR, 0.633; P = .0007), and normal-like (HR, 0.467; P = .0005) subtypes all derived benefit from RIB treatment,...Patients with HER2E, LumA, LumB, and normal-like subtypes all exhibited a consistent PFS benefit with RIB treatment, while patients with basal-like ABC (RIB: 2%; PBO: 3%) did not. The HER2E subtype (RIB: 14%; PBO: 11%) exhibited the greatest relative reduction in risk of progression or death (61%) with RIB plus ET.
ER positive + PGR negative + HER-2 negative | Breast Cancer | ribociclib
Evidence: B - Late Trials
7 days ago
Neoadjuvant pyrotinib plus trastuzumab and chemotherapy for stage I-III HER2-positive breast cancer: Results of a single-arm pilot clinical trial(SABCS 2020)
19 eligible patients were administrated pyrotinib neoadjuvant therapy with epirubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab...The tpCR rate was 72.2% (95% CI: 46.5 - 90.3), and no recurrence or metastasis occurred during the short-term follow-up period...The objective response rate (ORR) was 100% (95% CI: 81.5 - 100) at the end of eighth cycle...HER2-positive breast cancer were assigned to receive eight cycles of neoadjuvant...
HER-2 positive | HER2 Positive Breast Cancer | trastuzumab + SHR-1258 + epirubicin
Evidence: B - Late Trials
7 days ago
ER positive + HER-2 negative | HER2 Negative Breast Cancer | palbociclib + letrozole
Evidence: B - Late Trials
7 days ago
Results from CONTESSA: A phase 3 study of tesetaxel plus a reduced dose of capecitabine versus capecitabine alone in patients with HER2-, hormone receptor + (HR+) metastatic breast cancer (MBC) who have previously received a taxane(SABCS 2020)
CONTESSA, which enrolled 685 patients, met the primary endpoint of improved PFS as assessed by the IRC. Median PFS was 9.8 months for tesetaxel plus a reduced dose of capecitabine versus 6.9 months for capecitabine alone, an improvement of 2.9 months [HR=0.716 (95% CI: 0.573- 0.895); p=0.003]. ORR was 57% for tesetaxel plus a reduced dose of capecitabine versus 41% for capecitabine alone (p=0.0002). OS data are immature. Tesetaxel plus capecitabine was associated with a manageable side effect profile consistent with previous clinical studies....An all-oral regimen of tesetaxel plus a reduced dose of capecitabine significantly improved PFS versus capecitabine alone.
HR positive + HER-2 negative | HER2 Negative Breast Cancer | capecitabine
Evidence: B - Late Trials
7 days ago
Myriad Genetics Announces Global Expansion of Myriad myChoice Tumor Testing in Europe and China(GlobeNewswire)
"Myriad Genetics, Inc…announced today the expansion of Myriad myChoice® tumor testing in several European markets and China…As part of the expansion in Europe, Myriad will license and provide technological support to leading pathology institutes in Germany and France. Additionally, Myriad will support European customers by performing testing out of its clinical laboratory at the company’s global headquarters in Salt Lake City. Also, the institutes in Europe will perform the tests with Myriad’s myChoice CDx PLUS assay. Myriad myChoice CDx PLUS is CE-marked in accordance with the In-Vitro Diagnostic Devices Directive (98/79/EC)...Another collaboration in China provides that Myriad will partner with Burning Rock Biotech, a leader in next generation sequencing technology for precision oncology, to provide myChoice for HRD testing in Phase III clinical studies and clinics throughout China. Myriad will provide Burning Rock with access to its proprietary myChoice technology."
Myriad myChoice® CDx / Myriad Genetics
Clinical | Licensing / partnership
7 days ago
Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100(J Clin Oncol)
NON-SUPPORTIVE SENSITIVE EVIDENCE: JAVELIN Gastric 100 did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1–positive population.
Gastroesophageal Junction Adenocarcinoma | avelumab
Evidence: C3 – Early Trials -> B - Late Trials
8 days ago
Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100(J Clin Oncol)
NON-SUPPORTIVE SENSITIVE EVIDENCE: JAVELIN Gastric 100 did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1–positive population.
Gastric Cancer | avelumab
Evidence: C3 – Early Trials -> B - Late Trials
8 days ago
Clinical Genomics announces Medicare coverage applicable to COLVERA®(Clinical Genomics Press Release)
"Clinical Genomics…today announced that Novitas Solutions…updated its Local Coverage Determination applicable to biomarkers in oncology, including COLVERA...Novitas updated the Local Coverage Determination (‘LCD’): Biomarkers for Oncology (L35396) to allow Medicare coverage for COLVERA for medically necessary tests performed on or after July 1, 2020. This determination applies to patients across the United States covered by the Centers for Medicare and Medicaid Services (‘CMS’) whose claims for testing are submitted by Clinical Genomics in New Jersey. Medicare beneficiaries currently account for more than 50% of the COLVERA tests ordered by physicians and other licensed clinicians. Subsequent to the publication of the updated coverage determination, Clinical Genomics has received payment for numerous COLVERA tests that meet appropriate use criteria."
COLVERA™ / Clinical Genomics
Reimbursement
9 days ago
Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial(The Lancet)
Median progression-free survival was 13·93 months (95% CI 11·73–not evaluable) with selinexor, bortezomib, and dexamethasone and 9·46 months (8·11–10·78) with bortezomib and dexamethasone (hazard ratio 0·70 [95% CI 0·53–0·93], p=0·0075)….A once-per-week regimen of selinexor, bortezomib, and dexamethasone is a novel, effective, and convenient treatment option for patients with multiple myeloma.
Multiple Myeloma | bortezomib + selinexor
Evidence: B - Late Trials
10 days ago
Agilent Receives Expanded FDA Approval for PD-L1 IHC 22C3 pharmDx in Triple-Negative Breast Cancer(Businesswire)
"Agilent Technologies...announced it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as an aid in identifying patients with triple-negative breast cancer (TNBC) for treatment with KEYTRUDA® (pembrolizumab)...PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA. The expanded use of PD-L1 IHC 22C3 pharmDx strengthens the ability of pathologists to identify patients who may be eligible for treatment with KEYTRUDA."
pembrolizumab
PD-L1 IHC 22C3 pharmDx / Agilent Tech
FDA event
10 days ago
NeoGenomics to offer mobile phlebotomy services for liquid biopsy tests(NeoGenomics Press Release)
"NeoGenomics...announced today the launch of a mobile phlebotomy service for its blood-based tests, including InVisionFirst®-Lung, its advanced non-small cell lung cancer liquid biopsy test, and the NeoLAB® liquid biopsy suite of tests encompassing solid tumor and hematologic cancers...NeoGenomics will arrange for the blood sample collection at the patient's desired location and cover the expense of the mobile phlebotomy blood service."
InVisionFirst®-Lung / Inivata; NeoLAB® Solid Tumor Liquid Biopsy / NeoGenomics
Launch
10 days ago
FDA
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated...Triple-Negative Breast Cancer (TNBC)...in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA approved test.
PD-L1 expression | Triple Negative Breast Cancer | pembrolizumab
Evidence: B - Late Trials -> A1 - Approval
11 days ago
Adaptive Biotechnologies announces collaboration with GSK to measure minimal residual disease with clonoSEQ® assay across its hematology and oncology portfolio(Adaptive Biotechnologies Press Release)
"Adaptive Biotechnologies Corporation…today announced a collaboration with GlaxoSmithKline plc (GSK) to use its clonoSEQ® Assay to assess minimal residual disease (MRD) in GSK’s portfolio of hematology products...As part of the non-exclusive, pan-portfolio translational collaboration, Adaptive’s clonoSEQ Assay also may be used in GSK hematology clinical trials to generate data supporting the clinical value of monitoring MRD in the context of patient care."
clonoSEQ / Adaptive Biotech
Licensing / partnership
12 days ago
Surface Oncology Announces FDA Fast Track Designation Granted by U.S. Food and Drug Administration for SRF388 to Treat Liver Cancer(Surface Oncology Press Release)
Surface Oncology...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SRF388 for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer, who have been previously treated with standard therapies, such as vascular endothelial growth factor targeted agents and programmed death-ligand (PD-L1) blockade.
Hepatocellular Cancer | SRF388
Evidence: B - Late Trials
13 days ago
Deciphera Presents Data from QINLOCK (Ripretinib) Program at the Connective Tissue Oncology Society (CTOS) 2020 Virtual Annual Meeting(Deciphera Pharmaceuticals)
Ripretinib demonstrated activity across all KIT/PDGFRA mutations in patients with fourth-line advanced gastrointestinal stromal tumor: Analysis from the phase 3 INVICTUS study...QINLOCK demonstrated clinically meaningful activity in patients with fourth-line and fourth-line plus GIST (n=129) with multiple, heterogeneous genetic subsets of KIT/PDGFRA mutations. QINLOCK showed a median progression free survival (PFS) benefit of 6.3 months...
KIT mutation | Gastrointestinal Stromal Tumor | ripretinib
Evidence: C3 – Early Trials -> B - Late Trials
13 days ago
Deciphera Presents Data from QINLOCK (Ripretinib) Program at the Connective Tissue Oncology Society (CTOS) 2020 Virtual Annual Meeting(Deciphera Pharmaceuticals)
Ripretinib demonstrated activity across all KIT/PDGFRA mutations in patients with fourth-line advanced gastrointestinal stromal tumor: Analysis from the phase 3 INVICTUS study...QINLOCK demonstrated clinically meaningful activity in patients with fourth-line and fourth-line plus GIST (n=129) with multiple, heterogeneous genetic subsets of KIT/PDGFRA mutations. QINLOCK showed a median progression free survival (PFS) benefit of 6.3 months...
PDGFRA mutation | Gastrointestinal Stromal Tumor | ripretinib
Evidence: C3 – Early Trials -> B - Late Trials
13 days ago
Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer(GlobeNewswire)
...Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s lead compound, CPI-613® (devimistat), for the treatment of metastatic pancreatic cancer.
Pancreatic Cancer | devimistat
Evidence: B - Late Trials
14 days ago
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients…(Merck (MSD) Press Release)
KEYTRUDA plus LENVIMA met the trial’s primary endpoint of progression-free survival (PFS) and its key secondary endpoints of overall survival (OS) and objective response rate (ORR), demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat (ITT) study population.
Renal Cell Carcinoma | pembrolizumab + lenvatinib
Evidence: B - Late Trials
14 days ago
NICE recommends new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukaemia(NICE)
NICE has also recommended venetoclax plus obinutuzumab as a new treatment option via the Cancer Drugs Fund, for people with untreated CLL without a 17p deletion or TP53 mutation for whom FCR or BR is suitable.
Chronic Lymphocytic Leukemia | venetoclax + obinutuzumab
Evidence: A2 - Guideline
14 days ago
NICE recommends new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukaemia(NICE)
NICE has...recommended a new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukaemia (CLL)...Venetoclax plus obinutuzumab will be offered as a first-line treatment to people with CLL, with certain genetic abnormalities (such as a 17p deletion or TP53 mutation).
Chr del(17p) | Chronic Lymphocytic Leukemia | venetoclax + obinutuzumab
Evidence: A2 - Guideline
14 days ago
NICE recommends new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukaemia(NICE)
NICE has...recommended a new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukemia (CLL)...Venetoclax plus obinutuzumab will be offered as a first-line treatment to people with CLL, with certain genetic abnormalities (such as a 17p deletion or TP53 mutation).
TP53 mutation | Chronic Lymphocytic Leukemia | venetoclax + obinutuzumab
Evidence: A2 - Guideline
14 days ago
FDA
LENVIMA is a kinase inhibitor that is indicated...For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
Thyroid Gland Carcinoma | lenvatinib
Evidence: A1 - Approval
14 days ago
FDA
LENVIMA is a kinase inhibitor that is indicated...In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior antiangiogenic therapy.
Renal Cell Carcinoma | lenvatinib
Evidence: A2 - Guideline -> A1 - Approval
14 days ago
FDA
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated...for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed followin concurrent platinum-based chemotherapy and radiation therapy.
Non Small Cell Lung Cancer | durvalumab
Evidence: A2 - Guideline -> A1 - Approval
14 days ago
EarlyCDT-Lung patent expiry: 2027 in US(N+1 Singer)
A subscription to Thomson ONE is required to gain full access to report 70739637; Page no: 2; REPORT TITLE: "Oncimmune Holdings Plc- Initiating coverage- N+1 Singer - Oncimmune Holdings - A growth platform - Initiation and FY20 results"; AUTHOR: Thomason, Edward, et al; DATE: 10/30/2020
EarlyCDT®-Lung / Oncimmune
Patent
14 days ago
Foundation Medicine Expands Indication for FoundationOne Liquid CDx to be used as a Companion Diagnostic for LYNPARZA(Businesswire)
“Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for LYNPARZA® (olaparib). As a companion diagnostic, FoundationOne Liquid CDx will use a blood-based biopsy to identify patients with BRCA1, BRCA2 and/or ATM alterations in metastatic castration-resistant prostate cancer (mCRPC) who may be appropriate for treatment with LYNPARZA.”
olaparib
FoundationOne® Liquid CDx / Roche
FDA event
14 days ago
266 Tumour mutation burden (TMB) and efficacy outcomes in the phase III DANUBE study of advanced urothelial carcinoma (UC)(SITC 2020)
The phase III DANUBE study assessed the efficacy of the PD-L1 inhibitor durvalumab (D), alone or in combination with the CTLA-4 inhibitor tremelimumab (T), versus standard of care chemotherapy (SoC) for the first-line treatment of unresectable, locally advanced or metastatic UC. Among 1032 patients randomised in DANUBE...For D vs SoC, bTMB and tTMB were not associated with OS or PFS at any cutoff. For D+T, stronger associations between bTMB and OS as well as PFS were observed with increasing bTMB cutoffs (table 1). At the bTMB cutoff ≥ 24 mut/Mb, 12-month OS rates were 76.7% for D+T and 54.3% for SoC, whereas for bTMB < 24 mut/Mb, 12-month OS rates were 53.4% for D+T and 51.2% for SoC. Similar trends for both OS and PFS were observed with tTMB. Both bTMB and tTMB are potentially useful biomarkers for enriching responses to D+T in previously untreated, advanced UC. Neither bTMB nor tTMB was associated with better outcomes for D monotherapy.
TMB-H | Urothelial Cancer | durvalumab
Evidence: B - Late Trials
15 days ago
266 Tumour mutation burden (TMB) and efficacy outcomes in the phase III DANUBE study of advanced urothelial carcinoma (UC)(SITC 2020)
The phase III DANUBE study assessed the efficacy of the PD-L1 inhibitor durvalumab (D), alone or in combination with the CTLA-4 inhibitor tremelimumab (T), versus standard of care chemotherapy (SoC) for the first-line treatment of unresectable, locally advanced or metastatic UC. Among 1032 patients randomised in DANUBE...For D vs SoC, bTMB and tTMB were not associated with OS or PFS at any cutoff. For D+T, stronger associations between bTMB and OS as well as PFS were observed with increasing bTMB cutoffs (table 1). At the bTMB cutoff ≥ 24 mut/Mb, 12-month OS rates were 76.7% for D+T and 54.3% for SoC, whereas for bTMB < 24 mut/Mb, 12-month OS rates were 53.4% for D+T and 51.2% for SoC. Similar trends for both OS and PFS were observed with tTMB. Both bTMB and tTMB are potentially useful biomarkers for enriching responses to D+T in previously untreated, advanced UC. Neither bTMB nor tTMB was associated with better outcomes for D monotherapy.
TMB-H | Urothelial Cancer | durvalumab + CP-675206
Evidence: C3 – Early Trials -> B - Late Trials
15 days ago
307 Atezolizumab plus vemurafenib and cobimetinib provides favorable survival outcomes in patients with high tumor mutation burden and proinflammatory gene signature in the phase 3 IMspire150 study(SITC 2020)
...the magnitude of the PFS benefit with A+V+C vs P+V+C was markedly higher in patients with high TMB (≥10 mutations/Mb) compared with patients with low TMB (<10 mutations/Mb) in whom the benefit between treatment arms was comparable...
TMB-H | Melanoma | vemurafenib + atezolizumab + cobimetinib
Evidence: B - Late Trials
15 days ago
307 Atezolizumab plus vemurafenib and cobimetinib provides favorable survival outcomes in patients with high tumor mutation burden and proinflammatory gene signature in the phase 3 IMspire150 study(SITC 2020)
514 patients were randomized 1:1 to A+V+C (n=256) or P+V+C (n=258)….The PFS and DOR benefits were more evident in patients with high IFN-gamma or TMB >10 mutations/Mb.
IFNG-H | Melanoma | vemurafenib + atezolizumab + cobimetinib
Evidence: B - Late Trials
15 days ago
307 Atezolizumab plus vemurafenib and cobimetinib provides favorable survival outcomes in patients with high tumor mutation burden and proinflammatory gene signature in the phase 3 IMspire150 study(SITC 2020)
The phase 3 IMspire150 study (NCT02908672) showed that first-line atezolizumab (A) combined with vemurafenib (V) + cobimetinib (C) improved progression-free survival (PFS) vs placebo (P) + V + C in patients with BRAFV600 mutation–positive advanced melanoma...The magnitude of the PFS benefit with A+V+C was further enhanced in patients with high TMB and PD-L1– compared with patients with high TMB and PD-L1+.
TMB-H + PD-L1 negative | Melanoma | vemurafenib + atezolizumab + cobimetinib
Evidence: B - Late Trials
15 days ago
Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia(AstraZeneca Press Release)
AstraZeneca’s Calquence (acalabrutinib), a next-generation selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.
Chronic Lymphocytic Leukemia | acalabrutinib
Evidence: A1 - Approval
15 days ago
Comparison of three scoring methods using the FDA-approved 22C3 immunohistochemistry assay to evaluate PD-L1 expression in breast cancer and their association with clinicopathologic factors.(PubMed)
Our findings indicate that the three scoring methods with a 1% cutoff are different in their sensitivity for PD-L1 expression and their associations with clinicopathologic factors. Scoring by TCIC is the most sensitive way to identify PD-L1-positive breast cancer by immunohistochemistry. As a prognostic marker, our study suggests that PD-L1 is associated with worse clinical outcome, most often shown by the IC score; however, the other scores may also have clinical implications in some subgroups. Large clinical trials are needed to test the similarities and differences of these scoring methods for their predictive values in anti-PD-1/PD-L1 therapy.
PD-L1 expression | Breast Cancer + Triple Negative Breast Cancer + Solid Tumor
PD-L1 IHC 22C3 pharmDx / Agilent Tech
Clinical | FDA event | Journal
17 days ago
miR Scientific and Puerto Rico Government announce pioneering cooperation agreement to evaluate impact and deployment of its prostate cancer liquid biopsy test in Puerto Rico(PRNewswire)
"miR Scientific, LLC…and the Puerto Rico Health Insurance Administration ('ASES') announced today the signing of a cooperation agreement aimed at evaluating the clinical and economic utility of the miR Sentinel™ PCC4 Assay (miR Sentinel™ Prostate Test) and its potential impact in Puerto Rico…The agreement memorializes the explicit intent of deploying the Company's Sentinel™ Prostate Test commercially in Puerto Rico in an effort to alleviate the disease burden of prostate cancer on the Island."
Sentinel Prostate Test™ / miR Scientific
Licensing / partnership
18 days ago
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with Two Cycles of Chemotherapy for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer(Bristol-Myers Squibb Press Release)
...Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation.
Non Small Cell Lung Cancer | nivolumab + ipilimumab
Evidence: A1 - Approval
18 days ago
Astellas: XTANDI Approved In China To Treat Non-Metastatic Castration-Resistant Prostate Cancer(Astellas Press Release)
Japan-based Astellas Pharma Inc. (ALPMY) announced Friday that the China National Medical Products Administration or NMPA has approved XTANDI (enzalutamide soft capsules) to treat non-metastatic castration-resistant prostate cancer.
Prostate Cancer | enzalutamide
Evidence: A1 - Approval
18 days ago
Prosigna Breast Cancer Assay now approved for reimbursement in Germany(Veracyte Press Release)
"Veracyte, Inc…has approved its Prosigna® Breast Cancer Gene Signature Assay. The G-BA decision to reimburse the Prosigna test will provide access to the test for all breast cancer patients in Germany with HR+/HER2- early-stage breast cancer."
Prosigna™ Breast Cancer Prognostic Gene Signature Assay / NanoString Technologies
Reimbursement
18 days ago
NCCN
THIRD-LINE CHEMOTHERAPY REGIMENS FOR METASTATIC GERM CELL TUMORS...High Dose Chemotherapy NOT Previously Received...Useful in Certain Circumstances...Pembrolizumab (for MSI-H/dMMR or TMB-H tumors)
TMB-H | Germ Cell Tumors | pembrolizumab
Evidence: A2 - Guideline
19 days ago
Lynparza approved in the EU as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer(AstraZeneca Press Release)
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer.
HRD | Ovarian Cancer | olaparib + bevacizumab
Evidence: A1 - Approval
19 days ago
Lynparza approved in the EU for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer(AstraZeneca Press Release)
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.
BRCA1 mutation | Prostate Cancer | olaparib
Evidence: A1 - Approval
19 days ago
European Medicines Agency
Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Chronic Lymphocytic Leukemia | obinutuzumab + acalabrutinib
Evidence: A2 - Guideline -> A1 - Approval
19 days ago
Lynparza approved in the EU for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer(AstraZeneca Press Release)
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.
BRCA2 mutation | Prostate Cancer | olaparib
Evidence: A1 - Approval
19 days ago
Five-Year Analysis of Murano Study Demonstrates Enduring Undetectable Minimal Residual Disease (uMRD) in a Subset of Relapsed/Refractory Chronic Lymphocytic Leukemia (R/R CLL) Patients (Pts) Following Fixed-Duration Venetoclax-Rituximab (VenR) Therapy (Tx)(ASH 2020)
In the VenR cohort, uMRD at EOT is associated with improved OS. Unmutated IGVH, del(17p) and GC (≥3 CNV) are associated with higher rates of MRD conversion and subsequent PD after attaining uMRD at EOT. Overall, a substantial proportion of pts who completed Ven Tx retained uMRD 36 mo after treatment cessation, displaying durable response following 2-yr fixed-duration VenR.
Chr del(17p) | Chronic Lymphocytic Leukemia | venetoclax + rituximab
Evidence: B - Late Trials
20 days ago
461 Results of Venetoclax and Azacitidine Combination in Chemotherapy Ineligible Untreated Patients with Acute Myeloid Leukemia with IDH 1/2 Mutations(ASH 2020)
IDH1/2 mut pts achieved higher CR+CRh rates with Ven+Aza treatment as compared to pts with IDH not detected (72%/60%)....Ven+Aza compared to Aza monotherapy resulted in higher response rates, longer DoR, and mOS among treatment-naïve pts with IDH1/2 mut ineligible for intensive chemotherapy.
IDH1 mutation | Acute Myelogenous Leukemia | venetoclax
Evidence: B - Late Trials
20 days ago
461 Results of Venetoclax and Azacitidine Combination in Chemotherapy Ineligible Untreated Patients with Acute Myeloid Leukemia with IDH 1/2 Mutations(ASH 2020)
IDH1/2 mut pts achieved higher CR+CRh rates with Ven+Aza treatment as compared to pts with IDH not detected (72%/60%)....Ven+Aza compared to Aza monotherapy resulted in higher response rates, longer DoR, and mOS among treatment-naïve pts with IDH1/2 mut ineligible for intensive chemotherapy.
IDH2 mutation | Acute Myelogenous Leukemia | venetoclax
Evidence: B - Late Trials
20 days ago
Pharmacogenomics Drives Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma after Autologous Transplantation: Results from the MCL0208 Multicenter, Phase III, Randomized Clinical Trial from the Fondazione Italiana Linfomi (FIL)(ASH 2020)
Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma...ABCB1 HET/POL predicted for a more favorable PFS vs WT in LM (3yPFS 85% vs 69% p<0.05, Fig.1A), as well as VEGFA HET/POL (3yPFS 85% vs 59% p<0.01, Fig.1B).
ABCB1 mutation + VEGFA mutation | Mantle Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
20 days ago
Outcomes of First-Line Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and High-Risk Genomic Features with up to 6.5 Years Follow-up: Integrated Analysis of Two Phase 3 Studies (RESONATE-2 and iLLUMINATE)(ASH 2020)
At 42 mo, PFS rates were significantly higher across high-risk genomic subgroups in ibr-treated pts (63-82%) compared with clb-treated pts (6-34%), and consistent PFS benefit with ibr was observed across all high-risk genomic subgroups....Improved outcome was also noted for pts with del(17p)/TP53 mutated/BIRC3 mutated, the highest risk category per Rossi 2013 (HR 1.05, 95% CI 0.54-2.04).
BIRC3 mutation | Small Lymphocytic Lymphoma | ibrutinib
Evidence: B - Late Trials
20 days ago
3023 Lenalidomide As Maintenance Therapy after R-CHOP Has No Protecting Effect for Central Nervous System Relapse in Frontline Treatment of Diffuse Large B-Cells Lymphoma. an Ancillary Studies of the Remarc Study(ASH 2020)
Median age was 68 (58-80), 392 pts (63%) had elevated LDH, 575 pts (89%) presented disseminated disease...We retrospectively classified patients into groups of low- (n= 30, 5%), intermediate- (n= 377, 61%), and high-risk (n=215, 35%) CNS-IPI. MYC, MYC/BCL2, MYC/BCL2/BCL6 rearrangements were present in 10, 5 and 1 pts respectively. MYC expression alone, double expressor (DEL) (MYC/BLC2) were present in 79 pts (40%) and 71 pts (34%), respectively.
LDH elevation | Diffuse Large B Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
20 days ago
3023 Lenalidomide As Maintenance Therapy after R-CHOP Has No Protecting Effect for Central Nervous System Relapse in Frontline Treatment of Diffuse Large B-Cells Lymphoma. an Ancillary Studies of the Remarc Study(ASH 2020)
Median age was 68 (58-80), 392 pts (63%) had elevated LDH, 575 pts (89%) presented disseminated disease...We retrospectively classified patients into groups of low- (n= 30, 5%), intermediate- (n= 377, 61%), and high-risk (n=215, 35%) CNS-IPI. MYC, MYC/BCL2, MYC/BCL2/BCL6 rearrangements were present in 10, 5 and 1 pts respectively. MYC expression alone, double expressor (DEL) (MYC/BLC2) were present in 79 pts (40%) and 71 pts (34%), respectively.
MYC rearrangement | Diffuse Large B Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
20 days ago
3023 Lenalidomide As Maintenance Therapy after R-CHOP Has No Protecting Effect for Central Nervous System Relapse in Frontline Treatment of Diffuse Large B-Cells Lymphoma. an Ancillary Studies of the Remarc Study(ASH 2020)
Median age was 68 (58-80), 392 pts (63%) had elevated LDH, 575 pts (89%) presented disseminated disease...We retrospectively classified patients into groups of low- (n= 30, 5%), intermediate- (n= 377, 61%), and high-risk (n=215, 35%) CNS-IPI. MYC, MYC/BCL2, MYC/BCL2/BCL6 rearrangements were present in 10, 5 and 1 pts respectively. MYC expression alone, double expressor (DEL) (MYC/BLC2) were present in 79 pts (40%) and 71 pts (34%), respectively.
MYC rearrangement + BCL2 rearrangement | Diffuse Large B Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
20 days ago
Outcomes of First-Line Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and High-Risk Genomic Features with up to 6.5 Years Follow-up: Integrated Analysis of Two Phase 3 Studies (RESONATE-2 and iLLUMINATE)(ASH 2020)
At 42 mo, PFS rates were significantly higher across high-risk genomic subgroups in ibr-treated pts (63-82%) compared with clb-treated pts (6-34%), and consistent PFS benefit with ibr was observed across all high-risk genomic subgroups....Improved outcome was also noted for pts with del(17p)/TP53 mutated/BIRC3 mutated, the highest risk category per Rossi 2013 (HR 1.05, 95% CI 0.54-2.04).
BIRC3 mutation | Chronic Lymphocytic Leukemia | ibrutinib
Evidence: B - Late Trials
20 days ago
1150 The Echelon-2 Trial: 5-Year Results of a Randomized, Double-Blind, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in Frontline Treatment of Patients with CD30-Positive Peripheral T-Cell Lymphoma(ASH 2020)
At 5 years, frontline treatment with A+CHP continues to provide clinically meaningful improvement in PFS and OS versus CHOP, including ongoing remission in ~60% of pts with sALCL, with a manageable safety profile, including continued resolution or improvement of PN.
ALK negative | T Cell Non-Hodgkin Lymphoma | brentuximab vedotin
Evidence: B - Late Trials
20 days ago
Pharmacogenomics Drives Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma after Autologous Transplantation: Results from the MCL0208 Multicenter, Phase III, Randomized Clinical Trial from the Fondazione Italiana Linfomi (FIL)(ASH 2020)
Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma...ABCB1 HET/POL predicted for a more favorable PFS vs WT in LM (3yPFS 85% vs 69% p<0.05, Fig.1A), as well as VEGFA HET/POL (3yPFS 85% vs 59% p<0.01, Fig.1B).
VEGFA mutation | Mantle Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
20 days ago
Pharmacogenomics Drives Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma after Autologous Transplantation: Results from the MCL0208 Multicenter, Phase III, Randomized Clinical Trial from the Fondazione Italiana Linfomi (FIL)(ASH 2020)
Lenalidomide Efficacy and MRD Kinetics in Mantle Cell Lymphoma...ABCB1 HET/POL predicted for a more favorable PFS vs WT in LM (3yPFS 85% vs 69% p<0.05, Fig.1A), as well as VEGFA HET/POL (3yPFS 85% vs 59% p<0.01, Fig.1B).
ABCB1 mutation | Mantle Cell Lymphoma | lenalidomide
Evidence: B - Late Trials
20 days ago
1150 The Echelon-2 Trial: 5-Year Results of a Randomized, Double-Blind, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in Frontline Treatment of Patients with CD30-Positive Peripheral T-Cell Lymphoma(ASH 2020)
At 5 years, frontline treatment with A+CHP continues to provide clinically meaningful improvement in PFS and OS versus CHOP, including ongoing remission in ~60% of pts with sALCL, with a manageable safety profile, including continued resolution or improvement of PN.
ALK positive | Non-Hodgkin’s Lymphoma | brentuximab vedotin
Evidence: B - Late Trials
20 days ago
1150 The Echelon-2 Trial: 5-Year Results of a Randomized, Double-Blind, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in Frontline Treatment of Patients with CD30-Positive Peripheral T-Cell Lymphoma(ASH 2020)
At 5 years, frontline treatment with A+CHP continues to provide clinically meaningful improvement in PFS and OS versus CHOP, including ongoing remission in ~60% of pts with sALCL, with a manageable safety profile, including continued resolution or improvement of PN.
ALK negative | Non-Hodgkin’s Lymphoma | brentuximab vedotin
Evidence: B - Late Trials
20 days ago
6 Poor Treatment Outcomes of Young (<60 Years) African American Patients (Pts) Diagnosed with Acute Myeloid Leukemia (AML) (Alliance)(ASH 2020)
To characterize molecular features we performed targeted sequencing of 81 genes in 1,339 AML pts treated on frontline Cancer and Leukemia Group B/Alliance for Clinical Trials in Oncology (Alliance) protocols based on standard intensity cytarabine/anthracycline induction...However, AA pts harboring FLT3-ITD or IDH2 mutations had shorter OS compared with wild-type pts (FLT3-ITD, HR=1.95, P=.03; IDH2, HR=2.17, P=.008).
FLT3-ITD mutation | Acute Myelogenous Leukemia | cytarabine
Evidence: B - Late Trials
20 days ago
6 Poor Treatment Outcomes of Young (<60 Years) African American Patients (Pts) Diagnosed with Acute Myeloid Leukemia (AML) (Alliance)(ASH 2020)
To characterize molecular features we performed targeted sequencing of 81 genes in 1,339 AML pts treated on frontline Cancer and Leukemia Group B/Alliance for Clinical Trials in Oncology (Alliance) protocols based on standard intensity cytarabine/anthracycline induction...However, AA pts harboring FLT3-ITD or IDH2 mutations had shorter OS compared with wild-type pts (FLT3-ITD, HR=1.95, P=.03; IDH2, HR=2.17, P=.008).
IDH2 mutation | Acute Myelogenous Leukemia | cytarabine
Evidence: B - Late Trials
20 days ago
6 Poor Treatment Outcomes of Young (<60 Years) African American Patients (Pts) Diagnosed with Acute Myeloid Leukemia (AML) (Alliance)(ASH 2020)
To characterize molecular features we performed targeted sequencing of 81 genes in 1,339 AML pts treated on frontline Cancer and Leukemia Group B/Alliance for Clinical Trials in Oncology (Alliance) protocols based on standard intensity cytarabine/anthracycline induction...Lastly, we performed uni- and multivariable outcome analyses for OS in our Alliance pts. Remarkably, being NPM1-mutated and not being AA were the only positive prognostic factors associated with longer OS in the final risk model (NPM1 mut vs wt, HR=0.72, P<.001; Caucasian vs AA, HR=0.72, P=.03).
NPM1 mutation | Acute Myelogenous Leukemia | cytarabine
Evidence: B - Late Trials
20 days ago
Strata Oncology announces Medicare Coverage of StrataNGS Comprehensive Genomic Profiling Test for patients with advanced solid tumors(Strata Oncology Press Release)
"Strata Oncology, Inc…announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), has established coverage of the StrataNGSTM test for patients with advanced stages (III or IV), recurrent, relapsed, refractory, and/ or metastatic solid tumors."
StrataNGS™ Test / Strata Oncology
Reimbursement
22 days ago
European Commission approves Roche’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer(Roche Press Release)
Roche today announced that the European Commission has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Hepatocellular Cancer | bevacizumab + atezolizumab
Evidence: A1 - Approval
22 days ago
Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up(ESMO.org)
The standard of care for ChT is cisplatin at a dose of 100 mg/m2 given on days 1, 22 and 43 of concomitant RT (70 Gy) [II, A].
Squamous Cell Carcinoma of Head and Neck | cisplatin
Evidence: A2 - Guideline
23 days ago
Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up(ESMO.org)
Pembrolizumab in combination with platinum/5-FU and pembrolizumab monotherapy are two approved regimens for patients with recurrent/metastatic SCCHN expressing PD-L1 (CPS 1) [I, A; ESMO-MCBS v1.1 score:4]. ChT plus pembrolizumab is recommended when rapid tumour shrinkage is needed.
PD-L1 expression | Squamous Cell Carcinoma of Head and Neck | pembrolizumab
Evidence: A2 - Guideline
23 days ago
Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up(ESMO.org)
Platinum/5-FU/cetuximab remains the standard therapy for recurrent/metastatic patients with SCCHN not expressing PD-L1 [I, A; ESMO-MCBS v1.1 score: 3]. TPeX is also a treatment option in this population [II, B].
Squamous Cell Carcinoma of Head and Neck | cetuximab
Evidence: A2 - Guideline
23 days ago
Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up(ESMO.org)
Platinum/5-FU/cetuximab remains the standard therapy for recurrent/metastatic patients with SCCHN not expressing PD-L1 [I, A; ESMO-MCBS v1.1 score: 3]. TPeX is also a treatment option in this population [II, B].
Squamous Cell Carcinoma of Head and Neck | 5-fluorouracil
Evidence: A2 - Guideline
23 days ago
Inivata announces collaboration with Maverick Therapeutics for use of RaDaR™ Assay(Inivata Press Release)
"Inivata…today announces a collaboration with Maverick Therapeutics (‘Maverick’) for the use of Inivata’s RaDaR™ assay for the detection and monitoring of residual disease and recurrence. RaDaR will be used to monitor circulating tumor DNA (ctDNA) in patients enrolled in the Phase 1/2 study of MVC-101, Maverick’s lead program candidate."
RaDaR™ assay / Inivata
Licensing / partnership
24 days ago
Epic Sciences and Predicine jointly announce strategic partnership to expand liquid biopsy offerings to biopharmaceutical partners(Epic Sciences Press Release)
"Epic Sciences, Inc. and Predicine, Inc. today announced they have entered into a global strategic partnership to offer biopharmaceutical companies access to both Predicine’s ctDNA-based testing and Epic’s CTC-based testing. Predicine’s lead offering is PredicineATLASÔ, the broadest CLIA-certified ctDNA-based assay that analyzes 600 cancer-related genes, using next generation sequencing. Epic’s CTC-based platform offers testing of AR-V7, AR-N term, PSMA, ER, PR and other phenotypic tests. The combination of both approaches allows pharmaceutical partners engaged in clinical trials to measure both genotypic and phenotypic markers from a single blood draw."
Oncotype DX AR-V7 Nucleus Detect® test / Epic Sciences; PredicineATLAS™ / Predicine
Licensing / partnership
24 days ago
Characterizing benefit from temozolomide in MGMT promoter unmethylated and methylated glioblastoma: a systematic review and meta-analysis(Neuro Oncol)
The median OS for patients with unmethylated GBM treated with RT/TMZ pooled from 5 phase III studies (N = 655) was 14.11 months (95% confidence interval [CI], 13.18–15.04) with a median PFS of 4.99 months (95% CI, 4.25–5.72)...TMZ should be withheld for patients with unmethylated GBM...
MGMT unmethylation | Glioblastoma | temozolomide
Evidence: B - Late Trials
25 days ago
NCCN
Pembrolizumab (for myxofibrosarcoma, undifferentiated pleomorphic sarcoma [UPS], cutaneous angiosarcoma and undifferentiated sarcomas)...
Fibrosarcoma | pembrolizumab
Evidence: A2 - Guideline
25 days ago
NCCN
Gastrointestinal Stromal Tumors: Useful in certain circumstances…Larotrectinib or entrectinib (for NTRK gene-fusion GISTs)…
NTRK1 fusion | Gastrointestinal Stromal Tumor | larotrectinib
Evidence: C3 – Early Trials -> A2 - Guideline
25 days ago
NCCN
Gastrointestinal Stromal Tumors: Useful in certain circumstances…Cabozantinib…
Gastrointestinal Stromal Tumor | cabozantinib tablet
Evidence: A2 - Guideline
25 days ago
NCCN
Gastrointestinal Stromal Tumors: Useful in certain circumstances…Larotrectinib or entrectinib (for NTRK gene-fusion GISTs)…
NTRK2 fusion | Gastrointestinal Stromal Tumor | larotrectinib
Evidence: C3 – Early Trials -> A2 - Guideline
25 days ago
NCCN
Gastrointestinal Stromal Tumors: Useful in certain circumstances…Larotrectinib or entrectinib (for NTRK gene-fusion GISTs)…
NTRK3 fusion | Gastrointestinal Stromal Tumor | larotrectinib
Evidence: C3 – Early Trials -> A2 - Guideline
25 days ago
NCCN
For PDGFRA exon 18 mutations, consider dasatinib (for PDGFRA D842V mutation) or imatinib (for imatinib-sensitive PDGFRA exon 18 mutations).
PDGFRA exon 18 mutation | Gastrointestinal Stromal Tumor | imatinib
Evidence: A2 - Guideline
25 days ago
NCCN
Gastrointestinal Stromal Tumors: First-line therapy…Preferred Regimens…Imatinib (category 1)...
Gastrointestinal Stromal Tumor | imatinib
Evidence: A2 - Guideline
25 days ago
NCCN
Gastrointestinal Stromal Tumors: Useful in certain circumstances…Larotrectinib or entrectinib (for NTRK gene-fusion GISTs)…
NTRK3 fusion | Gastrointestinal Cancer | entrectinib
Evidence: C3 – Early Trials -> A2 - Guideline
25 days ago
NCCN
Gastrointestinal Stromal Tumors: Useful in certain circumstances…Larotrectinib or entrectinib (for NTRK gene-fusion GISTs)…
NTRK2 fusion | Gastrointestinal Cancer | entrectinib
Evidence: C3 – Early Trials -> A2 - Guideline
25 days ago
NCCN
Gastrointestinal Stromal Tumors: Useful in certain circumstances…Larotrectinib or entrectinib (for NTRK gene-fusion GISTs)…
NTRK1 fusion | Gastrointestinal Cancer | entrectinib
Evidence: C3 – Early Trials -> A2 - Guideline
25 days ago
NCCN
Gastrointestinal Stromal Tumors: Useful in certain circumstances…Dasatinib (for patients with PDGFRA D842V mutation)…
PDGFRA D842V | Gastrointestinal Stromal Tumor | dasatinib
Evidence: C3 – Early Trials -> A2 - Guideline
25 days ago
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer(PRNewswire)
"Roche...today announced U.S. Food and Drug Administration (FDA) approval of expanded claims for the cobas® EGFR Mutation Test v2 as a companion diagnostic (CDx) for a broad group of therapies in the treatment of non-small cell lung cancer (NSCLC). This claim expansion allows the test to be used as a CDx for all five currently FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies targeting EGFR mutations L858R and Exon 19 Deletions in accordance with the approved therapeutic product labeling. The group claim will also enable the test to be used as a CDx for any future approved EGFR TKI therapies targeting the same mutations, without the need to conduct individual clinical studies with the test for each new therapy."
cobas® EGFR Mutation Test v2 / Roche
FDA event
25 days ago
FDA ACCEPTS FOR PRIORITY REVIEW LIBTAYO® (CEMIPLIMAB-RWLC) FOR ADVANCED NON-SMALL CELL LUNG CANCER WITH PD-L1 EXPRESSION OF >=50%(Regeneron Pharmaceuticals Press Release)
...Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.
PD-L1 overexpression | Non Small Cell Lung Cancer | cemiplimab
Evidence: B - Late Trials
26 days ago
Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial(Lancet Oncol)
In this randomised, double-blind, multicentre, phase 3 trial, patients aged 18 years or older with relapsed or refractory multiple myeloma…median progression-free survival according to independent review committee was 22·4 months (95% CI 15·3–not estimable) with venetoclax...The primary endpoint was met with a significant improvement in independent review committee-assessed progression-free survival with venetoclax versus placebo plus bortezomib and dexamethasone.
Multiple Myeloma | venetoclax + bortezomib + dexamethasone
Evidence: B - Late Trials
26 days ago
European Commission approves Zejula (niraparib) as first-line monotherapy maintenance treatment in advanced ovarian cancer(GSK Press Release)
GlaxoSmithKline (GSK) plc today announced the European Commission has approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as first-line monotherapy maintenance treatment for adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy.
Ovarian Cancer | niraparib
Evidence: A1 - Approval
26 days ago
Enhertu granted Priority Review in the US for the treatment of HER2-positive metastatic gastric cancer(AstraZeneca Press Release)
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
HER-2 positive | Gastroesophageal Junction Adenocarcinoma | fam-trastuzumab deruxtecan-nxki
Evidence: B - Late Trials
27 days ago
Exact Sciences to acquire Thrive Earlier Detection, becoming a leader in blood-based, multi-cancer screening(Exact Sciences Press Release)
"Exact Sciences Corp...and Thrive Earlier Detection Corp. ('Thrive'),...announced they have entered into a definitive agreement under which Exact Sciences will acquire Thrive for cash and stock consideration of up to $2.15 billion.The transaction was unanimously approved by both companies' Boards of Directors and is anticipated to close during the first quarter of 2021, subject to regulatory approval and the satisfaction of other conditions...We are proud to take our partnership to the next level by leveraging Exact Sciences' established R&D team and highly accurate testing platform to augment development of CancerSEEK and accelerate its commercialization."
CancerSEEK / Thrive Earlier Detection
Licensing / partnership
27 days ago
FDA Approves New FoundationOne Liquid CDx Companion Diagnostic Indications for Three Targeted Therapies That Treat Advanced Ovarian, Breast and Non-Small Cell Lung Cancer(Businesswire)
"Foundation Medicine, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne®Liquid CDx for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies. The new indications are for Piqray® (alpelisib) in advanced or metastatic breast cancer; Rubraca® (rucaparib) in advanced ovarian cancer; and Alecensa® (alectinib) in a certain type of metastatic non-small cell lung cancer (mNSCLC). The FDA also approved a label expansion for FoundationOne Liquid CDx to report additional select copy number alterations and genomic rearrangements."
alpelisib + rucaparib
FoundationOne® Liquid CDx / Roche
FDA event
27 days ago
DRACEN PHARMACEUTICAL’S DRP-104 GRANTED U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER(Dracen Pharma Press Release)
Dracen Pharmaceuticals...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s novel glutamine antagonist DRP-104 for the treatment of advanced, previously treated non-small cell lung cancer (NSCLC) patients whose tumors express mutations in KEAP1, NFE2L2 and/or STK11.
NFE2L2 mutation + STK11 mutation | Non Small Cell Lung Cancer | DRP-104
Evidence: B - Late Trials
28 days ago
DRACEN PHARMACEUTICAL’S DRP-104 GRANTED U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER(Dracen Pharma Press Release)
Dracen Pharmaceuticals...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s novel glutamine antagonist DRP-104 for the treatment of advanced, previously treated non-small cell lung cancer (NSCLC) patients whose tumors express mutations in KEAP1, NFE2L2 and/or STK11.
STK11 mutation | Non Small Cell Lung Cancer | DRP-104
Evidence: B - Late Trials
28 days ago
DRACEN PHARMACEUTICAL’S DRP-104 GRANTED U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER(Dracen Pharma Press Release)
Dracen Pharmaceuticals...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s novel glutamine antagonist DRP-104 for the treatment of advanced, previously treated non-small cell lung cancer (NSCLC) patients whose tumors express mutations in KEAP1, NFE2L2 and/or STK11.
KEAP1 mutation | Non Small Cell Lung Cancer | DRP-104
Evidence: D – Preclinical -> B - Late Trials
28 days ago
DRACEN PHARMACEUTICAL’S DRP-104 GRANTED U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER(Dracen Pharma Press Release)
Dracen Pharmaceuticals...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s novel glutamine antagonist DRP-104 for the treatment of advanced, previously treated non-small cell lung cancer (NSCLC) patients whose tumors express mutations in KEAP1, NFE2L2 and/or STK11.
NFE2L2 mutation | Non Small Cell Lung Cancer | DRP-104
Evidence: B - Late Trials
28 days ago
A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER(Front Oncol)
JUNIPER was a Phase III, multicenter, randomized, open-label trial of abemaciclib versus erlotinib in patients with stage IV NSCLC and a detectable mutation in codons 12 or 13 of the KRAS oncogene, who progressed after platinum-based chemotherapy and 1 additional therapy (could include immune checkpoint inhibitor therapy)....Median PFS was 3.6 months (95% CI: 2.8, 3.8) with abemaciclib and 1.9 months (95% CI: 1.9, 2.0) with erlotinib (HR = 0.583 [95% CI: 0.470, 0.723]; p <.000001). ORR was 8.9% and 2.7% (p = .010), and the disease control rate was 54.4% and 31.7% (p <.001) with abemaciclib and erlotinib, respectively.
KRAS G12C | Non Small Cell Lung Cancer | abemaciclib
Evidence: B - Late Trials
29 days ago
A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER(Front Oncol)
JUNIPER was a Phase III, multicenter, randomized, open-label trial of abemaciclib versus erlotinib in patients with stage IV NSCLC and a detectable mutation in codons 12 or 13 of the KRAS oncogene, who progressed after platinum-based chemotherapy and 1 additional therapy (could include immune checkpoint inhibitor therapy)....Median PFS was 3.6 months (95% CI: 2.8, 3.8) with abemaciclib and 1.9 months (95% CI: 1.9, 2.0) with erlotinib (HR = 0.583 [95% CI: 0.470, 0.723]; p <.000001). ORR was 8.9% and 2.7% (p = .010), and the disease control rate was 54.4% and 31.7% (p <.001) with abemaciclib and erlotinib, respectively.
KRAS G13C | Non Small Cell Lung Cancer | abemaciclib
Evidence: B - Late Trials
29 days ago